MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS

Model Number	CRUS6A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2021).
Event or Problem Description
It was reported that during a recanalization procedure, the tip allegedly had foreign material.It was further reported that the catheter tip allegedly broke-off inside the patient.Patient status was unknown.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 6s crosser cto recanalization catheter was returned for evaluation.The device appeared to be clean.The distal end core wire along with tip of the catheter and marker band were detached and not returned.No functional testing due to the condition of the sample.Therefore, the investigation is confirmed for the alleged detachment of device or device component.However, the investigation is inconclusive for the alleged foreign material as there is no evidence provided to confirm the foreign material present in the device.A definitive root cause for the alleged foreign material and detachment of device or device component could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 08/2021 section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a recanalization procedure, the tip allegedly had foreign material.It was further reported that the catheter tip allegedly broke-off inside the patient.Patient status was unknown.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11612650
• Report Number: 2020394-2021-00777
• Device Sequence Number: 16907111
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CRUS6A
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFDV0756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention